Professional Documents
Culture Documents
English
ResMed.com/AirMiniApp
ENGLISH
Welcome
The ResMed AirMini™ system combines ResMed’s AirMini self-
adjusting pressure machine, masks and the AirMini by ResMed App.
WARNING
Read this entire guide before using the machine.
CAUTION
In the US, Federal law restricts this device to sale by or on the order
of a physician.
Contraindications
Positive airway pressure therapy may be contraindicated in some
patients with the following pre-existing conditions:
• severe bullous lung disease
• pneumothorax
• pathologically low blood pressure
• dehydration
• cerebrospinal fluid leak, recent cranial surgery, or trauma.
Adverse effects
You should report unusual chest pain, severe headache, or increased
breathlessness to your prescribing physician. An acute upper respiratory
tract infection may require temporary discontinuation of treatment.
English 1
The following side effects may arise during the course of therapy with
the machine:
• drying of the nose, mouth, or throat
• nosebleed
• bloating
• ear or sinus discomfort
• eye irritation
• skin rashes.
At a glance
The AirMini system includes the following:
• AirMini: the AirMini machine, power supply unit, drawstring bag
and one of the following:
• AirMini setup pack - F20: Air tubing, F20 connector OR
• AirMini setup pack - N20: Air tubing, N20 connector, HumidX,
HumidX Plus OR
• AirMini mask pack for P10: Air tubing, AirFit P10 for AirMini mask
(M), P10 cushion (S), P10 cushion (L), HumidX, HumidX Plus, AirFit
P10 headgear clips.
2
Your AirMini system
Your AirMini system is comprised of the AirMini machine and one mask
pack or one setup pack.
English 3
Your AirMini machine is designed to work with ResMed’s AirMini app.
However, the AirMini app is not essential to operate the machine. For
more information on the AirMini app, refer to Using your machine with
the AirMini app or the AirMini app Patient eHelp.
4
Set up your machine
1. Plug the power supply unit
into the machine and the
power outlet. The connector
has an angled edge so that
the power cord can only be
inserted into the machine
one way.
2. Connect the gray end of the
AirMini tubing firmly to the
air outlet.
English 5
Connect your mask
1. Fit your mask as instructed in the mask user guide.
2. Attach the connector to your mask.
Start therapy
1. Start therapy by pressing
the Start/Stop button or
breathe normally if
SmartStart™ is enabled.
Stop therapy
1. Remove your mask.
2. Press the Start/Stop button or wait until the machine stops if
SmartStop is activated.
6
Comfort features
Ramp Time, Pressure Relief and SmartStart are enabled on your
machine.
Ramp Time
Designed to make the beginning of therapy more comfortable, Ramp
Time is the period during which pressure gradually increases from a
lower start pressure to the prescribed treatment pressure.
Pressure Relief
When Pressure Relief is enabled and turned on, you may find it easier
to breathe out. This can help you get used to therapy.
Note: Pressure Relief must first be enabled by your provider.
SmartStart
When SmartStart is turned on, therapy starts automatically when you
breathe into your mask.
SmartStop
When SmartStop is turned on, therapy stops automatically after a few
seconds when you remove your mask.
English 7
Connecting your machine and smart device
Before connecting the AirMini machine to a smart device, ensure that
the latest version of the AirMini app is installed on the smart device. If
not, download the app from the App StoreSM or the Google Play store.
1. Ensure your machine is set up correctly and plugged into a power
source.
2. On your smart device, enable Bluetooth.
3. Open the AirMini app.
The first time you open the AirMini app, you will be asked to
consent to the use of cookies, to accept ResMed’s terms of use and
privacy policies, and to permit the AirMini app to upload your therapy
data to the cloud.
Four links on the Welcome page provide access to additional
information about cookie use, ResMed’s terms of use and privacy
policies and uploading data to the cloud:
• To open and read an explanation of the way cookies are used to
improve your experience with the AirMini app, click the Learn
More link.
Tap Done (iOS™) or the Back button (Android™) to return to the
Welcome page.
• To open and read ResMed’s terms of use, click the Terms link.
Tap Done (iOS) or the Back button (Android) to return to the
Welcome page.
• To open and read ResMed’s privacy notice, click the Privacy
link.
Tap Done (iOS) or the Back button (Android) to return to the
Welcome page.
• To learn more about data privacy, click the my data link.
Tap Done (iOS) or the Back button (Android) to return to the
Welcome page.
8
To provide consent and accept policies:
• To provide consent for the use of cookies, leave the cookies
check box selected. To deny consent for the use of cookies,
deselect the box.
Note: The check box for cookie consent is selected by default.
Therefore, no action is required to provide your consent.
• To accept ResMed’s terms of use and privacy notice, select the
terms and privacy check box.
• To provide consent for the AirMini app to upload data to the
cloud, select the data upload box.
Notes:
• If you agree to allow the AirMini app to upload your therapy
data to the cloud, it will be uploaded from the AirMini app to a
secure server.
• After you have agreed to have your data uploaded, these data
transfers can be turned on or off in the Preferences section
of the More menu.
• Once you turn on data transfers in the Preferences section of
the More menu, all available therapy data on the device will
be uploaded to the cloud, not just data generated from that
date forward.
• Data will continue to be uploaded to the cloud until you turn
off the transfers in the Preferences section of the More
menu.
• If you turn off data transfers in the Preferences section of the
More menu, data generated from that point forward will not
be uploaded to the cloud. However, data transferred to the
cloud previously will remain in the cloud.
4. Once selections are complete on the Welcome page, tap Continue.
5. On your machine, press the Bluetooth button when prompted by
the AirMini app.
English 9
6. On your smart device, tap Connect.
When your AirMini machine is discovered, the machine name
appears in the machine selection list.
7. Select the machine name from the list to connect.
8. The first time you pair your AirMini machine with your smart device,
you will need to perform the authentication procedure.
When prompted by the AirMini app, authenticate by entering the
four-digit key located on the back of your machine.
Alternatively, you can tap Scan code. If permission has not been
granted already, you will be prompted by the AirMini app to allow
the use of your smart device's camera and then to position the
machine’s QR code within the camera's viewing frame.
Note: The QR code is located on the back of your AirMini machine.
9. Tap Done.
10
Cleaning and maintenance
It is important that you regularly clean your AirMini machine to make
sure you receive optimal therapy. The following sections will help you
with disassembly, cleaning and checking your machine.
WARNING
• As part of good hygiene, always follow cleaning instructions.
Some cleaning products may damage the air tubing and affect
its function, or leave harmful residual vapours that could be
inhaled if not rinsed thoroughly.
• The AirMini connectors and AirFit P10 for AirMini contain a vent
system to prevent carbon dioxide build-up in the mask. The vent
system must be kept clean and clear of contamination in order
to function correctly. Blocking or modifying the vent system
may result in excessive carbon dioxide rebreathing.
• Regularly clean your AirMini tubing, connectors and mask
components to receive optimal therapy and to prevent the
growth of germs that can adversely affect your health.
• Regularly inspect the HumidX/HumidX Plus and follow the
cleaning and maintenance instructions to prevent the growth of
germs that can adversely affect your health.
CAUTION
If any visible deterioration of a system component is apparent
(cracking, discoloration, tears etc.), the component should be
discarded and replaced.
English 11
Disassembling
Remove the connector (F20 and N20 only)
1. Remove the connector
from the mask by pressing
the side buttons and
pulling it away.
Disconnect the AirMini tubing (N20 and AirFit P10 for AirMini only)
1. Disconnect the vent
module from the AirMini
tubing by gently twisting it
and pulling the two pieces
apart.
12
Remove the HumidX/HumidX Plus (N20 and AirFit P10 for AirMini
only)
1. Disconnect the mask tube
from the vent module by
gently twisting and pulling
the two pieces apart. If you
are using the HumidX or
HumidX Plus, remove it
from the vent module.
Note: The HumidX and
HumidX Plus cannot be
washed.
Unplug the machine
1. Disconnect the AirMini
tubing from the machine
by pressing the side
buttons on the cuff and
pulling it away.
2. Unplug the power supply
unit from the power outlet
and the machine.
English 13
Inspect the HumidX/HumidX Plus
1. Check daily for any signs of damage or blockages caused by dirt or
dust.
2. It must be replaced within 30 days after opening.
3. When the HumidX/HumidX Plus is not being used, store it in a clean,
dry location.
Note: HumidX/HumidX Plus cannot be washed.
14
5. Check that there is no dirt or dust in the vent holes.
English 15
Change the air filter
Replace at least every 6 months. It cannot be washed.
Check and replace it more often if there are any holes or blockages
caused by dirt or dust.
To change the air filter:
1. Slide the air filter cover off and remove the old air filter.
2. Insert a new air filter and replace the air filter cover.
Notes:
• Make sure the air filter cover is fitted at all times to prevent water
and dust from entering the machine.
• The use of ResMed approved hypoallergenic filter will result in a
small reduction in the accuracy of the delivered pressure at high
leaks.
Reprocessing
The AirMini tubing, AirMini connectors, vent module and
HumidX/HumidX Plus must be discarded and replaced, as they can not
be disinfected and can not be used between other patients.
For mask cleaning instructions, see your mask user guide.
16
Traveling
You can take your AirMini machine with you wherever you go. Make
sure you have the appropriate power supply for the region you are
traveling to. For information on purchasing, contact your care provider.
Traveling by airplane
For some airlines, medical devices do not count toward carry-on
luggage limits. Please check with your airline for their policy regarding
medical equipment.
You can use your AirMini machine on a plane as it meets the Federal
Aviation Administration (FAA) requirements. Air travel compliance
letters can be downloaded and printed from www.resmed.com.
When using the machine on an airplane:
• When connected to power, disable Bluetooth (enter airplane mode)
by pressing and holding the Bluetooth button for at least ten
seconds until the indicator light is white.
• Do not use the AirMini app.
• Use the Start/Stop button on your machine to start therapy,
• To reconnect Bluetooth (exit airplane mode), press the Bluetooth
button.
Troubleshooting
If you have any problems, have a look at the following troubleshooting
topics. If you are not able to fix the problem, contact your care provider
or ResMed. Do not try to open the machine.
Problem/possible cause Solution
English 17
Problem/possible cause Solution
The AirMini system may be assembled Make sure your AirMini system is correctly
incorrectly. assembled. Refer to Setting up and starting
therapy for more information.
Air pressure in my mask seems too low / It feels like I am not getting enough air
Ramp may be in progress. Using the AirMini app, confirm the Ramp
function has been enabled. If so, wait for
air pressure to build up or turn Ramp Time
off using the AirMini app.
HumidX or vent might be blocked. Inspect the HumidX and vent for blockages
or damage. Refer to Cleaning and
maintenance for more information.
HumidX may be wet. The HumidX should be dry when starting
therapy. Check if HumidX is wet and
replace as necessary.
18
Problem/possible cause Solution
English 19
Problem/possible cause Solution
20
General warnings and cautions
WARNING
• Make sure that you arrange the air tubing so that it will not twist
around the head or neck.
• Keep the power cord away from hot surfaces.
• Make sure the power cord and plug are in good condition and
the equipment is not damaged.
• If you notice any unexplained changes in the performance of the
machine, if it is making unusual sounds, if the machine or the
power supply are dropped or mishandled, or if the enclosure is
broken, discontinue use and contact your care provider or your
ResMed Service Center.
• Do not open or modify the machine. There are no user
serviceable parts inside. Repairs and servicing should only be
performed by an authorized ResMed service agent.
• Beware of electrocution. Do not immerse the machine, power
supply or power cord in water. If liquids are spilled into or onto
the machine, unplug the machine and let the parts dry. Always
unplug the machine before cleaning and make sure that all parts
are dry before plugging it back in.
• Do not use with oxygen. Any sources of oxygen must be located
more than 1 m away from the machine to avoid risk of fire and
burns.
• Do not perform any maintenance tasks while the machine is in
operation.
• Use only AirMini masks and accessories that allow for normal
breathing to avoid asphyxiation.
• The use of accessories other than those specified for the
machine is not recommended. This may result in increased
electromagnetic emissions or decreased immunity of the
machine and result in improper operation.
English 21
• The machine should not be used adjacent to or stacked with
other equipment. If adjacent or stacked use is necessary, the
machine should be observed to verify normal operation in the
configuration in which it will be used.
• The F20, N20 and P10 connectors for AirMini are fitted with
vents. The F20 connector for AirMini is also fitted with an AAV.
The AAV and vents have specific safety functions to prevent
carbon dioxide build-up in the mask. The AAV and vents should
be kept clean and not covered or blocked. The connectors
should not be used if the vent or AAV are damaged as they will
not be able to perform their safety functions. The connectors
should be replaced if the valves of the vent or AAV are
damaged, distorted or torn.
• The machine is not intended to be operated by persons
(including children) with reduced physical, sensory or mental
capabilities without adequate supervision by a person
responsible for the patient’s safety.
• The device has not been tested or certified for use in the vicinity
of X-ray, CT or MRI equipment. Do not bring the device within
13 ft (4 m) of X-ray or CT equipment. Never bring the device into
an MR environment.
CAUTION
• Use only ResMed AirMini parts, masks and accessories with the
machine. Non-ResMed AirMini parts may reduce the
effectiveness of the treatment, may result in excess carbon
dioxide rebreathing and/or damage the machine. For
compatibility information, refer to www.resmed.com for more
information.
• Blocking the air tubing and/or air inlet of the machine while in
operation could lead to overheating of the machine.
22
• Keep the area around the machine dry, clean and clear of
anything (eg, clothes, pillows or bedding) that could block the
air inlet or cover the power supply unit.
• Do not use bleach, chlorine, alcohol, or aromatic-based
solutions, moisturizing or antibacterial soaps or scented oils to
clean the machine or air tubing. These solutions may cause
damage and reduce the life of the products.
• Do not insert any USB cable into the machine or attempt to plug
the power supply unit into a USB device. This may cause
damage to the machine or USB device.
Technical specifications
Units are expressed in cm H2O and hPa. 1 cm H2O is equal to 0.98 hPa.
Power supply unit
AC input range: 100–240V, 50–60Hz, 0.5-0.3A
115V, 400Hz for aircraft use, 0.4A
DC output: 24V 0.83A
Typical power consumption: 6.3W
Peak power consumption: 27W
If power is interrupted during therapy, the machine will automatically restart therapy
when power is restored.
AirMini power
Standby power consumption: 1W
Environmental conditions
Operating temperature: +41°F to +95°F (+5°C to +35°C)
Note: Under extreme ambient temperature
conditions (104°F/40°C) the air and parts
of the tubing near the mask may reach
temperatures up to 109°F/43°C. These
parts of the tubing are not in contact with
the user and the machine remains safe
under these extreme conditions.
Operating humidity: 10 to 95% relative humidity, non-
condensing
English 23
Operating altitude: Sea level to 8,500' (2,591 m); air pressure
range 1013 hPa to 738 hPa
Storage and transport temperature: -13°F to +158°F (-25°C to +70°C)
Storage and transport humidity: 5 to 95% relative humidity, non-
condensing
Air filter
Standard: Material: Polyester non woven fiber
Average arrestance: >75% when tested to
EN779
Hypoallergenic: Material: Blended synthetic fibers in a
polypropylene carrier
Efficiency: >80% (average) when tested to
EN 13274-7
AirMini machine
Dimensions: 5.4" (W) x 3.3" (D) x 2.1"(H)
136 mm (W) x 84 mm (D) x 52 mm (H)
Weight: 10.6 oz (300 g)
Housing construction: Flame retardant engineering thermoplastic
Air outlet: Proprietary connector, 16mm inner
diameter. Not compatible with EN ISO
5356-1 connectors.
AirMini air tubing
Material: Flexible plastic
Length: 6'2" (1.9 m)
Inner diameter: 0.6" (15 mm)
24
Electromagnetic compatibility
The AirMini complies with all applicable electromagnetic compatibility requirements
(EMC) according to IEC60601-1-2:2014, for residential, commercial and light industry
environments. Portable and mobile RF communications equipment should be used no
closer to any part of the machine, including cables, than the recommended 10 cm
separation distance. The AirMini has been designed to meet EMC standards. However,
should you suspect that the machine performance (eg, pressure or flow) is affected by
other equipment, move the machine away from the possible cause of interference.
The AirMini complies with Part 15 of the FCC Rules and Industry Canada license-exempt
RSS standards. Operation is subject to the following two conditions: This machine may
not cause harmful interference, and this machine must accept any interference received,
including interference that may cause undesired operation.
FCC ID: QOQBT121, IC: 5123A-BGTBT121
Additional information regarding the FCC Rules and IC compliance for this machine can
be found on www.resmed.com/downloads/devices.
Aircraft use
ResMed confirms that machine meets the Federal Aviation Administration (FAA)
requirements (RTCA/DO-160, section 21, category M) for all phases of air travel.
Wireless technology
Technology used: Bluetooth
Connection types: SPP, iAP2, GATT
Frequency: 2402 to 2480 MHz
Max RF power output: +4 dBm
Operating range: 10 m (Class 2)
It is recommended that the machine is at a minimum distance of 0.43" (1.1cm) from the
body during operation. Not applicable to masks, air tubing or accessories.
IEC 60601-1 (Edition 3.1) classification
Class II (double insulation), Type BF, Ingress protection IP22.
Operating pressure range
AutoSet, AutoSet For Her, CPAP: 4 to 20 cm H2O (4 to 20 hPa)
English 25
Maximum single fault steady pressure
Machine will shut down in the presence of a single fault if the steady state pressure
exceeds 30 cm H2O (30 hPa) for more than 6 seconds or 40 cm H2O (40 hPa) for more
than 1 second.
Pneumatic flow path
1. Flow sensor
2. Blower
3. Pressure sensor
4. AAV (F20 connector only)
5. Vent
6. HumidX (N20, P10 connectors only)
7. Mask
8. Air tubing
9. Machine
10. Inlet filter
Pressure accuracy
Maximum static pressure variation at 10 cm H2O (10 hPa) according to
ISO 80601-2-70:2015:
Tested with full face mask: ±0.5 cm H20 (0.5 hPa)
Maximum dynamic pressure variation according to ISO 80601-2-70:2015
Machine with full face mask
Pressure 10 BPM 15 BPM 20 BPM
[cm H2O (hPa)]
4 0.5 0.7 1.0
8 0.5 0.7 1.0
12 0.5 0.7 1.0
16 0.5 0.7 1.0
20 0.5 0.7 1.0
26
Flow (maximum) at set pressures
The following are measured accordingly to ISO 80601-2-70:2015 at the end of the
specified air tubing:
Pressure AirMini machine and AirMini air tubing
cm H2O (hPa) L/min (including uncertainty)
4 119
8 116
12 112
16 108
20 105
Sound
Declared dual-number noise emission values in accordance with ISO 4871:1996
Pressure level measured according to ISO 29 dBA with uncertainty of 2 dBA
80601-2-70:2015 (CPAP mode)
Power level measured according to ISO 37 dBA with uncertainty of 2 dBA
80601-2-70:2015 (CPAP mode)
English 27
The A-weighted sound pressure level measured according to ISO 17510:2015:
Air tubing connected to AirMini F20 19 dBA with uncertainty of 3 dBA
connector with mask
Air tubing connected to AirMini N20 or 15 dBA with uncertainty of 3 dBA
P10 connectors with mask
The A-weighted sound power level measured according to ISO 17510:2015:
Air tubing connected to AirMini F20 27 dBA with uncertainty of 3 dBA
connector with mask
Air tubing connected to the AirMini N20 23 dBA with uncertainty of 3 dBA
or P10 connectors with mask
Pressure flow curve (ISO 17510:2015)
Pressure Flow
[cm H2O [L/min]
(hPa)]
4 21
8 26
12 29
16 31
20 33
Resistance
Inspiratory and expiratory resistance F20 connector
with AAV open to atmosphere
(ISO 17510:2015)
Inspiration at 50L/min 0.7 cm H2O (hPa)
Expiration at 50L/min 0.5 cm H2O (hPa)
AAV Pressures (ISO 17510:2015) F20 connector
Open-to-atmosphere pressure 0.9 cm H2O (hPa)
Closed-to-atmosphere pressure 1.0 cm H2O (hPa)
Design life
Machine, power supply unit: 5 years
Air tubing, connectors: 6 months
HumidX: 30 days
28
General
The patient is an intended operator.
Notes:
• The manufacturer reserves the right to change these specifications
without notice.
• The mask system does not contain PVC, DEHP or phthalates.
• This product is not made with natural rubber latex.
Symbols
The following symbols may appear on the product or packaging.
English 29
MR unsafe (do not use in the vicinity of an MRI device) (ASTM
Servicing
The AirMini machine is intended to provide safe and reliable operation
when operated in accordance with the instructions provided by
ResMed. ResMed recommends that the AirMini machine be inspected
and serviced by an authorized ResMed Service Centre if there is any
sign of wear or concern with device function. Otherwise, service and
inspection of the products generally should not be required during their
design life.
Limited warranty
ResMed Ltd (hereafter 'ResMed') warrants that your ResMed product
shall be free from defects in material and workmanship from the date of
purchase for the period specified in the following table:
30
Product Warranty period
• Mask systems (including mask frame, cushion, headgear 90 days
and tubing)—excluding single-use devices
• Accessories—excluding single-use devices
• Batteries for use in ResMed internal and external battery 6 months
systems
• CPAP machine (including external power supply units) 2 years
This warranty is only available to the initial consumer. It is not
transferable.
If the product fails under conditions of normal use, ResMed will repair
or replace, at its option, the defective product or any of its components.
This Limited Warranty does not cover: a) any damage caused as a result
of improper use, abuse, modification or alteration of the product; b)
repairs carried out by any service organization that has not been
expressly authorized by ResMed to perform such repairs; and c) any
damage or contamination due to cigarette, pipe, cigar or other smoke.
Warranty is void on product sold, or resold, outside the region of original
purchase.
Warranty claims on defective product must be made by the initial
consumer at the point of purchase.
This warranty replaces all other expressed or implied warranties,
including any implied warranty of merchantability or fitness for a
particular purpose. Some regions or states do not allow limitations on
how long an implied warranty lasts, so the above limitation may not
apply to you.
ResMed shall not be responsible for any incidental or consequential
damages claimed to have resulted from the sale, installation or use of
any ResMed product. Some regions or states do not allow the exclusion
or limitation of incidental or consequential damages, so the above
limitation may not apply to you.
This warranty gives you specific legal rights, and you may also have
other rights which vary from region to region. For further information on
your warranty rights, contact your local ResMed dealer or ResMed
office.
English 31
Warranty information for Australian customers
Our goods come with guarantees that cannot be excluded under the
Australian Consumer Law. You are entitled to a replacement or refund
for a major failure and for compensation for any other reasonably
foreseeable loss or damage. You are also entitled to have the goods
repaired or replaced if the goods fail to be of acceptable quality and the
failure does not amount to a major failure.
In addition to your rights and remedies under Australian Consumer Law
(and any other applicable law), ResMed Ltd ABN 30 003 765 142 of
1 Elizabeth Macarthur Drive, Bella Vista NSW 2153 (ResMed) warrants
that your ResMed product will be free from defects in material and
workmanship from the date of purchase for the period specified below.
Further information
If you have any questions or require additional information on how to
use the machine, contact your care provider.
English 33
ResMed Ltd
1 Elizabeth Macarthur Drive Bella Vista NSW 2153 Australia
See ResMed.com for other ResMed locations worldwide. AirMini, AutoSet, HumidX and SmartStart are
trademarks and/or registered trademarks of the ResMed family of companies. For patent and other intellectual
property information, see ResMed.com/ip. “Made for iPhone” means that an electronic accessory has been
designed to connect specifically to iPhone and has been certified by the developer to meet Apple performance
standards. Apple is not responsible for the operation of this device or its compliance with safety and
regulatory standards. Please note that the use of this accessory with iPhone may affect wireless performance.
Apple and the Apple logo are trademarks of Apple Inc., registered in the U.S. and other countries. App Store
is a service mark of Apple Inc. IOS is a trademark of Cisco, licensed to Apple Inc. Bluetooth is a registered
trademark of the Bluetooth SIG, Inc. Joy is a trademark of Procter & Gamble. The Android robot is reproduced
or modified from work created and shared by Google and used according to terms described in the Creative
Commons 3.0 Attribution License. Android, Google Play and the Google Play logo are trademarks of Google
Inc. Galaxy, Edge and Note are trademarks of Samsung. This product uses software developed by the ANTLR
project (http://www.antlr2.org). © 2018 ResMed Ltd. 388129/1 2018-05
ResMed.com
388129